New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:

12/21/2010

Trade Name:

INOmax

Generic Name or Proper Name (*):

nitric oxide

Indications Studied:

Prevention of bronchopulmonary dysplasia

Label Changes Summary:

* INOmax is not indicated for prevention of BPD in preterm neonates d 34 weeks gestational age.* Efficacy for the prevention of BPD in preterm infants was not established in three ldouble-blind, placebo-controlled clinical trials in a total of 2,149 preterm infants * Information on clinical trials, adverse reaction